MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LONGEVITY CONST LINER 50X28; PROSTHESIS, HIP

Catalog Number	00633405028
Medical Device Problem Codes	Off-Label Use (1494); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a hip revision approximately 1-year post implantation due to dislocation.During the procedure, the trilogy liner and competitor¿s head were replaced.No additional information available for the reported event.
Additional Manufacturer Narrative
(b)(4).G2: australia.The product was requested but was not returned by the hospital and will therefore not be sent to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
No additional information available for the reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a2; g3; h2; h4; h6 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined; however, an unknown competitor head was used with a zimmer biomet liner.As per instructions for use, compatibility states - due to the acquisition of pre-existing product lines, zimmer biomet or its affiliates has initiated a testing program to evaluate the compatibility of these devices with implants and components made or distributed by all zimmer biomet or its affiliates, which include zimmer gmbh (previously centerpulse orthopedics ltd.), zimmer trabecular metal technology, inc.(previously implex corp.), zimmer u.K.Ltd., zimmer austin, inc.(previously centerpulse orthopedics, inc.) and biomet orthopedic companies.Only authorized combinations should be used.It is unknown if this caused or contributed to the reported event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor trends.

• Brand Name: LONGEVITY CONST LINER 50X28
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23061624
• Report Number: 0001822565-2025-03419
• Device Sequence Number: 21252886
• Product Code: KWZ
• UDI-Device Identifier: 00889024668881
• UDI-Public: (01)00889024668881(17)291013(10)66867591
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00633405028
• Device Lot Number: 66867591
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK SHELL.UNK STEM.UNK COMPETITOR HEAD.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown